ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 2147 for:    Melanoma

Biomarkers for the Activity of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma (ICIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02673970
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Bart Neyns, Universitair Ziekenhuis Brussel

Brief Summary:
  1. Screen and recruitment: patients will be screened based on their prior history and intention to initiate treatment with an immune checkpoint inhibitor.
  2. Study phase:

    • Collection of baseline demographic data, prior disease history, nature of ICI therapy, outcome data of ICI therapy (treatment disposition, toxicity, tumor response and survival).
    • Collection of blood samples will be performed every 3 to 4 weeks for the first year on ICI therapy and every 6 to 12 weeks thereafter until the end of ICI therapy, disease progression, death or loss to follow-up. Collection of blood samples will be aligned with the visits necessary for the administration of the ICI therapy.
    • Collection of archival melanoma metastasis tissues will be performed on a continuous basis and be triggered by availability of such tissue following therapeutic resections of melanoma metastases.
  3. Follow-up phase

Condition or disease
Malignant Melanoma

Detailed Description:
  1. Screen and recruitment: patients will be screened based on their prior history and intention to initiate treatment with an immune checkpoint inhibitor. This screening of candidate patients by the investigators will be non-interventional. Patients that are considered eligible candidates will be invited to participate in this study and to Page 3/18 provide written informed consent.
  2. Study phase:

    • Collection of baseline demographic data, prior disease history, nature of ICI therapy, outcome data of ICI therapy (treatment disposition, toxicity, tumor response and survival).
    • Collection of blood samples will be performed every 3 to 4 weeks for the first year on ICI therapy and every 6 to 12 weeks thereafter until the end of ICI therapy, disease progression, death or loss to follow-up. Collection of blood samples will be aligned with the visits necessary for the administration of the ICI therapy.
    • Collection of archival melanoma metastasis tissues will be performed on a continuous basis and be triggered by availability of such tissue following therapeutic resections of melanoma metastases.
  3. Follow-up phase: patients who stop treatment with the immune checkpoint inhibitor will be followed-up for

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers for the Activity of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma
Study Start Date : October 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Group/Cohort
observational arm
From start treatment till date of death or date of cure, the patient will be followed for survival and adverse events on pembrolizumab



Primary Outcome Measures :
  1. explore the value of biomarkers present in blood, and tumor tissue for the purpose of predicting the efficacy of ICI therapy or for the purpose of monitoring the therapeutic effect of ICI therapy [ Time Frame: 1year ]
    explore the value of biomarkers present in blood, and tumor tissue for the purpose of predicting the efficacy of ICI therapy or for the purpose of monitoring the therapeutic effect of ICI therapy


Secondary Outcome Measures :
  1. Baseline demographic data, prior disease history, nature of ICI therapy, treatment disposition, adverse events [ Time Frame: 1year ]
    Baseline demographic data, prior disease history, nature of ICI therapy, treatment disposition, adverse events

  2. Tumor response according to the RECISTv1.1 and irRC criteria [ Time Frame: 1 year ]
    Tumor response according to the RECISTv1.1 and irRC criteria

  3. Survival (PFS, and OS) by Kaplan-Meier estimates [ Time Frame: 1year ]
    Survival (PFS, and OS) by Kaplan-Meier estimates

  4. Data collection on the nature and disposition of ICI therapy as well as its efficacy and treatment related adverse events will be collected on a non-interventional basis [ Time Frame: 1 year ]
    Data collection on the nature and disposition of ICI therapy as well as its efficacy and treatment related adverse events will be collected on a non-interventional basis


Biospecimen Retention:   Samples With DNA
Cllection of cell free DNA for mutational analysis


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patient with an unresectable stage III or stage IV melanoma treated with pembrolizumab
Criteria

Inclusion Criteria:

  1. Histologically confirmed malignant melanoma;
  2. AJCC Stage IIIC or IV melanoma with evaluable disease;
  3. Treatment with an immune checkpoint inhibitor;
  4. Willing and able to give written informed consent;
  5. Accessible for treatment and follow-up;

Exclusion Criteria:

  • non

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673970


Contacts
Contact: Bart Neyns, MD; PhD 024746040 bart.neyns@uzbrussel.be
Contact: Yanina Jansen, MD 024746040 yanina.jansen@uzbrussel.be

Locations
Belgium
UZ Brussel Recruiting
Jette, Brabant, Belgium, 1090
Contact: Bart Neyns, Phd,Md    0032(0)2477 64 15    bart.neyns@uzbrussel.be   
Principal Investigator: Bart Neyns, Phd,Md         
UZ Brussel Recruiting
Laken, Brussels, Belgium, 1090
Contact: Katrien Vandenbossche, study nurse    0032 2 477 54 47    katrien.vandenbossche@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Principal Investigator: Bart NEyns, MD; PhD Universitair Ziekenhuis Brussel

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bart Neyns, PhD MD Bart Neyns, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02673970     History of Changes
Other Study ID Numbers: 2014-BN-001
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Bart Neyns, Universitair Ziekenhuis Brussel:
Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas